Rapid exchange transcatheter valve delivery system

ABSTRACT

A delivery device for implanting a prosthetic heart valve. The device includes an inner shaft assembly, an outer sheath and a connector assembly. The inner shaft assembly defines a guide wire lumen. The outer sheath is slidably received over the inner shaft assembly, and forms an exit port proximate a distal end thereof. The connector assembly establishes a guide wire passageway between the guide wire lumen and the exit port. The connector assembly is configured to permit sliding movement of the outer sheath relative to the inner shaft assembly when deploying the prosthetic heart valve. The connector assembly can include first and second tubes that are slidable relative to one another in facilitating movement of the outer sheath relative to the inner shaft assembly.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of and claims the benefit of U.S.patent application Ser. No. 14/830,504 filed Aug. 19, 2015, now allowed,which claims the benefit of the filing date of U.S. Provisional PatentApplication Ser. No. 62/040,486, filed Aug. 22, 2014, the disclosures ofwhich are herein incorporated by reference in their entirety.

BACKGROUND

The present disclosure relates to delivery systems for implantingtranscatheter valves. More particularly, it relates to catheter-based,rapid exchange systems for implanting a stented prosthetic heart valve.

A human heart includes four heart valves that determine the pathway ofblood flow through the heart: the mitral valve, the tricuspid valve, theaortic valve, and the pulmonary valve. The mitral and tricuspid valvesare atrio-ventricular valves, which are between the atria and theventricles, while the aortic and pulmonary valves are semilunar valves,which are in the arteries leaving the heart. Ideally, native leaflets ofa heart valve move apart from each other when the valve is in an openposition, and meet or “coapt” when the valve is in a closed position.Problems that may develop with valves include stenosis in which a valvedoes not open properly, and/or insufficiency or regurgitation in which avalve does not close properly. Stenosis and insufficiency may occurconcomitantly in the same valve. The effects of valvular dysfunctionvary, with regurgitation or backflow typically having relatively severephysiological consequences to the patient.

Diseased or otherwise deficient heart valves can be repaired or replacedusing a variety of different types of heart valve surgeries. Oneconventional technique involves an open-heart surgical approach that isconducted under general anesthesia, during which the heart is stoppedand blood flow is controlled by a heart-lung bypass machine.

More recently, minimally invasive approaches have been developed tofacilitate catheter-based implantation of the valve prosthesis on thebeating heart, intending to obviate the need for the use of classicalsternotomy and cardiopulmonary bypass. In general terms, an expandableprosthetic valve is compressed about or within a catheter, insertedinside a body lumen of the patient, such as the femoral artery, anddelivered to a desired location in the heart.

The heart valve prosthesis employed with catheter-based, ortranscatheter, procedures generally includes an expandable multi-levelframe or stent that supports a valve structure having a plurality ofleaflets. The frame can be contracted during percutaneous transluminaldelivery, and expanded upon deployment at or within the native valve.One type of valve stent can be initially provided in an expanded oruncrimped condition, then crimped or compressed about a balloon portionof an inner catheter or inner shaft. The balloon is subsequentlyinflated to expand and deploy the prosthetic heart valve. With otherstented prosthetic heart valve designs, the stent frame is formed to beself-expanding. With these systems, the valved stent is crimped down toa desired size over an inner shaft and held in that compressed statewithin an outer sheath for transluminal delivery. Retracting the sheathfrom this valved stent allows the stent to self-expand to a largerdiameter, fixating at the native valve site. In more general terms,then, once the prosthetic valve is positioned at the treatment site, forinstance within an incompetent native valve, the stent frame structuremay be expanded to hold the prosthetic valve firmly in place. Oneexample of a stented prosthetic valve is disclosed in U.S. Pat. No.5,957,949 to Leonhardt et al., which is incorporated by reference hereinin its entirety.

In many transcatheter prosthetic heart valve delivery approaches, aguide wire is utilized to guide the catheter during delivery. The guidewire is preferably made of metal, and is routed through the tortuouspath of the patient's vasculature to a desired location at the nativevalve site. Once the guide wire is in place, the delivery device isadvanced over the guide wire and then operated to deploy the prostheticvalve. To accommodate the guide wire, the delivery device incorporatesan “over-the-wire” design, forming a central guide wire lumen thatextends an entire length of the outer sheath, for example from adistal-most opening in the inner shaft to a proximal opening or exitport at the device's handle. While well-accepted for stented prostheticheart valve implant procedures, implementation of the over-the-wireapproach may give rise to procedural complexities. For example, at leasttwo clinicians are typically needed; one to operate the delivery devicevia the handle assembly and another to directly manage the guide wireoutside of or beyond the handle assembly. Proper guide wire managementcan become increasingly intricate at various stages of the procedure,due in large part to the significant length of the guide wire outside ofthe patient. The delivery device is advanced over the pre-placed guidewire by inserting or “back-loading” a proximal end of the guide wireinto the distal guide wire port, which in turns leads to the guide wirelumen, of the delivery device. The guide wire thus must be sized suchthat with the distal end of the guide wire located at the delivery site,a remaining length of guide wire outside of the patient is commensuratewith (e.g., at least slightly longer than) a corresponding length of thedelivery device, and in particular a length of the guide wire lumen. Inother words, the guide wire employed with an over-the-wire system has alength at least double the length of the delivery device's outer sheath.This excessive length requires two clinicians, and increases the timenecessary to load or unload the delivery device relative to the guidewire.

Other catheter-based procedures otherwise utilizing one or more guidewires, such as coronary catheter procedures, address some of theover-the-wire concerns by incorporating what is commonly referred to asa “rapid exchange” design. In a rapid exchange system, the guide wireoccupies a lumen located only in the distal portion of the catheter. Theguide wire exits the catheter through a proximal guide wire port that islocated closer to the distal end of the catheter than to its proximalend, and extends in parallel along the outside of the proximal portionof the catheter. The rapid exchange configuration allows for the use ofmuch shorter guide wires (as compared to over-the-wire designs), whichenables a single clinician to handle the proximal end of the guide wireat the same time as the catheter at the point of entry into the patient.

Unfortunately, existing rapid exchange technology is not compatible withconventional stented prosthetic heart valve delivery devices. Unlikecoronary catheters or other rapid exchange catheters having a singleproximal guide wire port, the stented heart valve delivery device wouldeffectively require at least two openings or ports on the proximal side:one in the inner shaft and a second in the outer sheath. In order toload the guide wire into the delivery device, a structured pathwayconnecting the two proximal side guide wire openings or ports would benecessary. Existing stented heart valve delivery devices do notcontemplate rapid exchange, let alone provide requisite design features.Further, the operational requirements of stented heart valve deliverydevices (e.g., retraction of the outer sheath relative to the innershaft and the guide wire when deploying the valve) present distinctdesign obstacles for the structured pathway to be viable.

Although there have been multiple advances in transcatheter prostheticheart valves and related delivery systems and techniques, a need existsfor heart valve prosthesis delivery systems providing rapid exchangefeatures.

SUMMARY

Some aspects of the present disclosure relate to a delivery device forimplanting a stented prosthetic heart valve. The delivery deviceincludes an inner shaft assembly, an outer sheath and a connectorassembly. The inner shaft assembly defines a guide wire lumen. The outersheath is slidably received over the inner shaft assembly, and forms aguide wire exit port near a distal end thereof. The connector assemblyestablishes a guide wire passageway between the guide wire lumen and theguide wire exit port. In this regard, the connector assembly isconfigured to permit sliding movement of the outer sheath relative tothe inner shaft assembly when deploying the stented prosthetic heartvalve. In some embodiments, the connector assembly includes first andsecond tubes that collectively establish the guide wire passageway andare slidable relative to one another in facilitating movement of theouter sheath relative to the inner shaft assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view of a stented prosthetic heart valve useful withsystems, devices and methods of the present disclosure and in a normal,expanded condition;

FIG. 1B is a side view of the prosthetic heart valve of FIG. 1A in acompressed condition;

FIG. 2 is a side view of another exemplary heart valve stent useful withsystems, devices and methods of the present disclosure and in a normal,expanded condition;

FIG. 3A is an exploded, perspective view of stented prosthetic heartvalve delivery system in accordance with principles of the presentdisclosure;

FIG. 3B is a side view of the delivery system of FIG. 3A;

FIG. 4 is an enlarged, simplified cross-sectional view of a portion ofthe delivery system of FIG. 3A;

FIGS. 5A-5C illustrate assembly of the system of FIG. 3A, includingloading of a delivery device over a guide wire;

FIGS. 6A-6C illustrate portions of a method of implanting a stentedprosthetic heart valve with the system of FIG. 3A and in accordance withthe principles of the present disclosure;

FIG. 7 is a simplified side view of another stented prosthetic heartvalve delivery system in accordance with principles of the presentdisclosure;

FIGS. 8A and 8B are simplified, cross-sectional views of portions ofanother stented prosthetic heart valve delivery system in accordancewith principles of the present disclosure;

FIG. 9 is a simplified side view of portions of another stentedprosthetic heart valve delivery system in accordance with principles ofthe present disclosure;

FIG. 10A is a side view of a clip component useful with the system ofFIGS. 9; and

FIGS. 10B and 10C are side views illustrating insertion of a guide wireinto the clip of FIG. 10A.

DETAILED DESCRIPTION

Specific embodiments of the present disclosure are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal” are used in the following description with respect to aposition or direction relative to the treating clinician. “Distal” or“distally” are a position distant from or in a direction away from theclinician. “Proximal” and “proximally” are a position near or in adirection toward the clinician. As used herein with reference to animplanted valve prosthesis, the terms “distal”, “outlet”, and “outflow”are understood to mean downstream to the direction of blood flow, andthe terms “proximal”, “inlet”, or “inflow” are understood to meanupstream to the direction of blood flow. In addition, as used herein,the terms “outward” or “outwardly” refer to a position radially awayfrom a longitudinal axis of a frame of the valve prosthesis or deliverydevice and the terms “inward” or “inwardly” refer to a position radiallytoward a longitudinal axis of the frame of the valve prosthesis ordelivery device. As well the terms “backward” or “backwardly” refer tothe relative transition from a downstream position to an upstreamposition and the terms “forward” or “forwardly” refer to the relativetransition from an upstream position to a downstream position.

As referred to herein, stented transcatheter prosthetic heart valvesuseful with and/or as part of the various systems, devices and methodsof the present disclosure may assume a wide variety of differentconfigurations, such as a bioprosthetic heart valve having tissueleaflets or a synthetic heart valve having polymeric, metallic ortissue-engineered leaflets, and can be specifically configured forreplacing any of the four valves of the human heart. Thus, the stentedprosthetic heart valve useful with the systems, devices, and methods ofthe present disclosure can be generally used for replacement of a nativeaortic, mitral, pulmonic or tricuspid valve, or to replace a failedbioprosthesis, such as in the area of an aortic valve or mitral valve,for example.

In general terms, the stented prosthetic heart valves of the presentdisclosure include a stent or stent frame maintaining a valve structure(tissue or synthetic), with the stent frame having a normal, expandedcondition or arrangement and collapsible to a compressed condition orarrangement for loading within a delivery device. The stent frame isnormally constructed to self-deploy or self-expand when release from thedelivery device. In other embodiments, stent frames useful with systemsand devices of the present disclosure have a balloon-expandableconfiguration as is known in the art. The stents or stent frames aresupport structures that comprise a number of struts or wire segmentsarranged relative to each other to provide a desired compressibility andstrength to the prosthetic heart valve. The struts or wire segments arearranged such that they are capable of transitioning from a compressedor collapsed condition to a normal, radially expanded condition. Thestruts or wire segments can be formed from a shape memory material, suchas a nickel titanium alloy (e.g., Nitinol™). The stent frame can belaser-cut from a single piece of material, or can be assembled from anumber of discrete components.

With the above understanding in mind, one simplified, non-limitingexample of a stented prosthetic heart valve 30 useful with systems,devices and methods of the present disclosure is illustrated in FIG. 1A.As a point of reference, the prosthetic heart valve 30 is shown in anormal or expanded condition in the view of FIG. 1A; FIG. 1B illustratesthe prosthetic heart valve 30 in a compressed condition (e.g., whencompressively retained within an outer catheter or sheath as describedbelow). The prosthetic heart valve 30 includes a stent or stent frame 32and a valve structure 34. The stent frame 32 can assume any of the formsmentioned above, and is generally constructed so as to beself-expandable from the compressed condition (FIG. 1B) to the normal,expanded condition (FIG. 1A). In other embodiments, the stent frame 32can have a balloon-expandable configuration.

The valve structure 34 can assume a variety of forms, and can be formed,for example, from one or more biocompatible synthetic materials,synthetic polymers, autograft tissue, homograft tissue, xenografttissue, or one or more other suitable materials. In some embodiments,the valve structure 34 can be formed, for example, from bovine, porcine,equine, ovine and/or other suitable animal tissues. In some embodiments,the valve structure 34 can be formed, for example, from heart valvetissue, pericardium, and/or other suitable tissue. In some embodiments,the valve structure 34 can include or form one or more leaflets 36. Forexample, the valve structure 34 can be in the form of a tri-leafletbovine pericardium valve, a bi-leaflet valve, or another suitable valve.In some constructions, the valve structure 34 can comprise two or threeleaflets that are fastened together at enlarged lateral end regions toform commissural joints, with the unattached edges forming coaptationedges of the valve structure 34. The leaflets 36 can be fastened to askirt that in turn is attached to the frame 32. The upper ends of thecommissure points can define an inflow portion 38 corresponding to afirst or inflow end 40 of the prosthesis 30. The opposite end of thevalve can define an outflow portion 42 corresponding to a second oroutflow end 44 of the prosthesis 30. As shown, the stent frame 32 canhave a lattice or cell-like structure, and optionally forms or providescrowns 46 and/or eyelets 48 (or other shapes) at the outflow and inflowends 40, 44.

With the one exemplary construction of FIGS. 1A and 1B, the prostheticheart valve 30 can be configured (e.g., sized and shaped) for replacingor repairing an aortic valve. Alternatively, other shapes are alsoenvisioned, adapted to mimic the specific anatomy of the valve to berepaired (e.g., stented prosthetic heart valves useful with the presentdisclosure can alternatively be shaped and/or sized for replacing anative mitral, pulmonic or tricuspid valve). For example, FIG. 2illustrates another non-limiting example of a stent frame 50 portion ofanother prosthetic heart valve with which the systems, devices andmethods of the present disclosure are useful. In the normal or expandedcondition of FIG. 2, the stent frame 50 can be sized and shaped formitral valve implantation. Though not shown, the valve structureattached to the stent frame 50 defines an outflow portion 52 arranged ata first or outflow end 54, and an inflow portion 56 arranged at a secondor inflow end 58. As compared to the stent frame 32 of FIG. 1A, theinflow portion 56 can exhibit a more pronounced change in shape relativeto the corresponding outflow portion 52. Regardless, the stent frame 50can be forced and constrained to a compressed condition (not shown, butakin to the shape of FIG. 1A) during delivery, and will self-expand tothe natural condition of FIG. 2 upon removal of the constrainingforce(s). As reflected in FIG. 2, crowns 60 and/or eyelets 62 (or othershapes) optionally can be formed at one or both of the outflow andinflow ends 54, 58. Further, the stent frame 50 can optionally includeor carry additional structural components, such as support arm(s) 64.

With the above understanding of the stented prosthetic heart valves inmind, one embodiment of a delivery system 70 for percutaneouslydelivering the prosthesis is shown in simplified form in FIGS. 3A and3B. The delivery system 70 includes a delivery device 72 and at leastone guide wire 74. As described in greater detail below, the deliverydevice 72 is configured to slidably receive the guide wire 74 in a rapidexchange manner.

The delivery device 72 includes an outer sheath assembly 80, an innershaft assembly 82, a handle assembly 84, and a connector assembly 86.Details on the various components are provided below. In general terms,however, the delivery device 72 provides a delivery condition in which astented prosthetic heart valve (not shown) is loaded over the innershaft assembly 82 and is compressively retained within a capsule 88 ofthe outer sheath assembly 80. For example, the inner shaft assembly 82can include or provide a spindle or valve retainer 90 configured toselectively receive a corresponding feature (e.g., posts) provided withthe prosthetic heart valve stent frame. The outer sheath assembly 80 canbe manipulated to withdraw the capsule 88 proximally from over theprosthetic heart valve via operation of the handle assembly 84,permitting the prosthesis to self-expand and partially release from theinner shaft assembly 82. When the capsule 88 is retracted proximallybeyond the valve retainer 90, the stented prosthetic heart valve cancompletely release or deploy from the delivery device 72. The deliverydevice 72 can optionally include other components that assist orfacilitate or control complete deployment. Regardless, the connectorassembly 86 facilitates loading of the guide wire 74 within a guide wirelumen (hidden) of the delivery device 72 (e.g., extending along thevalve retainer 90) to a proximal guide wire exit port 92 in the outersheath assembly 80. In the loaded arrangement of FIG. 3B, then, theguide wire 74 extends proximally from the proximal guide wire exit port92 outside of the outer sheath assembly 80. Further, the connectorassembly 86 (hidden in FIG. 3B) is configured to permit proximalmovement of the outer sheath assembly 80 relative to the inner shaftassembly 82, such as when deploying the prosthetic heart valve.

Various features of the components 80-84 reflected in FIGS. 3A and 3Band as described below can be modified or replaced with differingstructures and/or mechanisms. Thus, the present disclosure is in no waylimited to the outer sheath assembly 80, the inner shaft assembly 82, orthe handle assembly 84 as shown and described below. Any constructionthat generally facilitates compressed loading of a stented prostheticheart valve over an inner shaft via a retractable outer sheath orcapsule is acceptable. Further, the delivery device 72 can optionallyinclude additional components or features, such as a flush portassembly, a recapture sheath (not shown), etc.

In some embodiments, the outer sheath assembly 80 defines proximal anddistal ends 100, 102, and includes the capsule 88 and an outer shaft104. The outer sheath assembly 80 can be akin to a catheter, defining alumen 106 (referenced generally) that extends from the distal end 102,through the capsule 88 and at least a portion of the outer shaft 104.The lumen 106 can be open at the proximal end 100 (e.g., the outer shaft104 can be a tube). The capsule 88 extends distally from the outer shaft104, and in some embodiments has a more stiffened construction (ascompared to a stiffness of the outer shaft 104) that exhibits sufficientradial or circumferential rigidity to overtly resist the expectedexpansive forces of the stented prosthetic heart valve (not shown) whencompressed within the capsule 88. For example, the outer shaft 104 canbe a polymer tube embedded with a metal braiding, whereas the capsule 88includes a laser-cut metal tube that is optionally embedded within apolymer covering. Alternatively, the capsule 88 and the outer shaft 104can have a more uniform or even homogenous construction (e.g., acontinuous polymer tube). Regardless, the capsule 88 is constructed tocompressively retain the stented prosthetic heart valve at apredetermined diameter when loaded within the capsule 88, and the outershaft 104 serves to connect the capsule 88 with the handle assembly 84.The outer shaft 104 (as well as the capsule 88) is constructed to besufficiently flexible for passage through a patient's vasculature, yetexhibits sufficient longitudinal rigidity to effectuate desired axialmovement of the capsule 88. In other words, proximal retraction of theouter shaft 104 is directly transferred to the capsule 88 and causes acorresponding proximal retraction of the capsule 88. In otherembodiments, the outer shaft 104 is further configured to transmit arotational force or movement onto the capsule 88.

The guide wire exit port 92 is formed in the outer shaft 104 proximatethe capsule 88. For example, the guide wire exit port 92 can beproximally spaced from a trailing end 108 of the capsule 88 by adistance on the order of 0.5-5.0 inches, although other locations arealso acceptable. However, the guide wire exit port 92 is desirablydistally spaced from the handle assembly 84 by a substantial distancesufficient to render the delivery device 70 to have rapid exchangeattributes. The guide wire exit port 92 can assume a variety of shapesand sizes (e.g., circular, elongated slot, etc.) appropriate forslidably receiving the guide wire 74.

The inner shaft assembly 82 can have various constructions appropriatefor supporting a stented prosthetic heart valve (not shown) relative tothe outer sheath assembly 80, and includes the valve retainer 90, anintermediate shaft 110 and a distal shaft 112. The intermediate shaft110 is sized to be slidably received within the outer sheath assembly 80and serves as a transition to the valve retainer 90. The intermediateshaft 110 can be a solid or tubular structure, and in some embodimentshas a rigid construction, such as a metal hypotube. Other, more flexiblematerials are also envisioned, such as flexible polymer tubing (e.g.,PEEK). The intermediate shaft 110 can be configured for direct mountingto the handle assembly 84. In other embodiments, the inner shaftassembly 82 can further include a proximal shaft (e.g., tube) 114interposed between the handle assembly 84 and the intermediate shaft110. With these and related construction, the intermediate shaft 110 canhave a more flexible construction as compared to the proximal shaft 114.

The distal shaft 112 is sized to be slidably received within the lumen106 of the outer sheath assembly 80, and is configured for mounting tothe valve retainer 90. The distal shaft 112 can be a flexible polymertube embedded with a metal braid. Other constructions are alsoacceptable so long as the distal shaft 112 exhibits sufficientstructural integrity to support a loaded, compressed stented prostheticheart valve (not shown). A tip 116 is optionally formed by, or attachedto, the distal shaft 112, and is akin to a nose cone having a distallytapering outer surface adapted to promote atraumatic contact with bodilytissue. The tip 116 can be fixed or slidable relative to the distalshaft 112. The distal shaft 112 forms a lumen (hidden) sized to slidablyreceive the guide wire 74 and that is open at a distal guide wire entryport 118.

The valve retainer 90 can assume various forms adapted to selectivelyreceive a corresponding feature (e.g., posts) provided with theprosthetic heart valve stent frame and/or to directly support a portionof a length of the stent frame in the compressed condition. In someembodiments, the valve retainer 90 can have a spindle-like shape asshown and described, for example, in Dwork et al., U.S. ApplicationPublication No. 2011/0098805 the entire teachings of which areincorporated by reference herein. The valve retainer 90 is configuredfor assembly to the intermediate shaft 110. The valve retainer 90 can beconstructed for placement over the distal shaft 112, or alternativelyfor assembly between the distal shaft 112 and the intermediate shaft110. Regardless, the valve retainer 90 forms a lumen (hidden) extendingbetween a distal opening 120 and a proximal opening (hidden).

The handle assembly 84 generally includes a housing 130 and one or moreactuator mechanisms 132 (referenced generally). The housing 130maintains the actuator mechanism(s) 132, with the handle assembly 84configured to facilitate sliding movement of the outer sheath assembly80 relative to other components (e.g., the inner shaft assembly 82) by auser via, for example, manipulation of one or more of the actuatormechanisms 132. The housing 130 can have any shape or size appropriatefor convenient handling by a user.

With the above general explanations of exemplary embodiments of thecomponents 80-84 in mind, portions of one embodiment of the connectorassembly 86 is shown in greater detail in FIG. 4. As a point ofreference, FIG. 4 illustrates the delivery device 72 in the deliverycondition, with the capsule 88 located over (and extending distallybeyond) the valve retainer 90. A guide wire lumen 140 is alsoidentified. The guide wire lumen 140 is open to the guide wire entryport 118 (FIG. 3A), and can be generated in various fashions as afunction of the mounting arrangement between the valve retainer 90 andthe distal shaft 112. The distal shaft 112 forms at least a portion ofthe guide wire lumen 140. With the exemplary embodiment of FIG. 4, thedistal shaft 112 terminates within the valve retainer 90 such that thelumen of the valve retainer 90 is also “part” of the guide wire lumen140. In other embodiments, the distal shaft 112 extends to a proximalface 142 of the valve retainer 90 such that the guide wire lumen 140 isentirely formed by the distal shaft 112. Regardless, the guide wirelumen 140 is open to a proximal opening 144, optionally formed in theproximal face 142 of valve retainer 90. Further, the intermediate shaft110 is attached to the valve retainer 90, for example at the proximalface 142, at a location off-set from the proximal opening 144.

With the above conventions in mind, the connector assembly 86establishes a guide wire passageway 150 between the proximal opening 144(and thus the guide wire lumen 140) and the guide wire exit port 92. Theguide wire passageway 150 is sized to slidably receive the guide wire 74(FIG. 3A). The connector assembly 86 is configured to permit slidingmovement of the outer sheath assembly 80 relative to the inner shaftassembly 82 (e.g., proximal retraction of the outer sheath assembly 80from the delivery arrangement of FIG. 4), transitioning between a firststate (FIG. 4) and a second state. In some embodiments, the connectorassembly 86 has a telescope-like construction, and includes a first tube160 and a second tube 162. The first and second tubes 160, 162 areslidably connected to one another and collectively define the guide wirepassageway 150. The first tube 160 is attached to, or is formed by, theouter shaft 104, whereas the second tube 162 is attached to, or isformed by, the valve retainer 90. While FIG. 4 reflects that the firsttube 160 has an inner diameter that is slightly greater than an outerdiameter of the second tube 162 (such that the second tube 162 isslidably received within the first tube 160), an opposite constructionis equally acceptable.

The first and second tubes 160, 162 can be formed of the same or similarmaterial, and in some embodiments are each a thin wall plastic extrudedpart. Other materials, such as metals, are also envisioned. The firsttube 160 can be mounted to the outer shaft 104 at the guide wire exitport 92 in various fashions as a function of the selected materials. Forexample, the first tube 160 can be adhered, welded, etc., to the outershaft 104. In other embodiments, the first tube 160 is manufactured aspart of the outer shaft 104. Regardless, the first tube 160 optionallyincorporates a thin wall construction, at least at the point ofintersection with the outer shaft 104, so as to readily permit slightpivoting movement of the first tube 160 relative to the outer shaft 104.

Similarly, the second tube 162 can be mounted to the valve retainer 90at the proximal opening 144 in various fashions as a function of theselected materials. For example, the second tube 162 can be adhered,welded, etc., to the valve retainer 90 (e.g., at the proximal face 142).The second tube 162 optionally incorporates a thin wall construction, atleast at the point of intersection with the valve retainer 90, so as toreadily permit slight pivoting movement of the second tube 162 relativeto the valve retainer 90.

In some embodiments, the guide wire lumen 140 extends along alongitudinal axis A of the valve retainer 90, such that the proximalopening 144 is centrally located along the proximal face 142. With thisconstruction, the second tube 162 also extends from a central locationof the proximal face 142, and the intermediate shaft 110 is radiallyoff-set from the longitudinal axis A at the point of attachment to thevalve retainer 90. Stated otherwise, with some constructions of thepresent disclosure, the intermediate shaft 110 and the valve retainer 90are not longitudinally aligned. Other configurations are alsoenvisioned. For example, the guide wire lumen 140 can deviate from thelongitudinal axis A, non-centrally locating the proximal opening 144,and thus the second tube 162, along the proximal face 142.Alternatively, the proximal opening 144 can be formed in a side of thevalve retainer 90. With either construction, the intermediate shaft 110can then be aligned with the longitudinal axis A if desired. Notably,while the intermediate shaft 110 optionally is a metal hypotube, inother embodiments, the intermediate shaft 110 can be a solid body thatdoes not otherwise form an internal lumen. Because the guide wire 74(FIG. 3A) does not extend through the intermediate shaft 110, theintermediate shaft 110 of the present disclosure can have a smallerdiameter as compared to inner shafts typically employed with stentedprosthetic heart valve delivery devices.

In yet other embodiments, at least a portion of the intermediate shaft110 is tubular and is connected to the valve retainer 90 at the proximalopening 144. The second tube 162, in turn, is connected to theintermediate shaft 110 proximal to the valve retainer 90 with the lumenof the second tube 162 being open to the lumen of the intermediate shaft110. With this alternative construction, then, the intermediate shaft110 can be connected to the valve retainer 90 along the longitudinalaxis A, with the guide wire lumen 140 effectively continuing from thevalve retainer 90 through a portion of the intermediate shaft 110 andopen to the second tube 162.

FIG. 5A illustrates an initial stage of loading the delivery device 72on to the guide wire 74, with the delivery device 72 in the deliverycondition (and the connector assembly 86 in the first state). As a pointof reference, the delivery device 72 will typically be loaded with astented prosthetic heart valve prior to loading on to the guide wire 74;for ease of illustration, the stented prosthetic heart valve is omittedfrom the views of FIGS. 5A-5C, but can assume any of the forms describedabove. With additional reference to FIG. 3A, a proximal end 170 of theguide wire 74 is first inserted into the distal guide wire entry port118, and then guided through the guide wire lumen 140 along the distalshaft 112. In the arrangement of FIG. 5A, the proximal end 170 hassubsequently progressed (via distal advancement of the delivery device72 over the guide wire 74 and/or proximal insertion of the guide wire 74into the delivery device 72) to location within the valve retainer 90.

As the guide wire 74 is further progressed relative to the deliverydevice 72 from the arrangement of FIG. 5A, the proximal end 170 passesthrough the proximal opening 144 and enters the second tube 162. Withfurther advancement, the guide wire passageway 150 directs the proximalend 170 to the guide wire exit port 92. In the loaded condition of FIG.5B, then, the guide wire 74 is slidably disposed within the guide wirelumen 140 and the guide wire passageway 150, and extends proximally fromthe guide wire exit port 92 along an exterior of the outer shaft 104,for example to a region of (but not within) the handle assembly 84 (FIG.3B).

While loaded over the guide wire 74, the delivery device 72 can betransitioned from the delivery condition of FIGS. 5A and 5B to thedeployment condition of FIG. 5C by proximally retracting the outersheath assembly 80 relative to the inner shaft assembly 82 (and/orvice-versa). With this movement, the connector assembly 86 transitionsfrom the first state of FIGS. 5A and 5B to the second state of FIG. 5C.More particularly, as the outer sheath and inner shaft assemblies 80, 82are moved relative to one another, the first tube 160 slides along thesecond tube 162 and/or vice-versa, accommodating the increasinglongitudinal distance between the guide wire exit port 92 and theproximal opening 144. In some embodiments, the first and second tubes160, 162 are dimensioned so as to remain in contact with one another inthe delivery condition such that the guide wire passageway 150 iscomplete in the second state. In other configurations, a distance oftravel of the outer sheath and inner shaft assemblies 80, 82 relative toone another in achieving the deployment condition is greater than thelength of interface between the first and second tubes 160, 162 in thefirst state (FIG. 5B), such that the first tube 160 alternativelydisconnects from the second tube 162 in the second state. Regardless,the guide wire 74 freely slides within the guide wire passageway 150 asthe first and second tubes 160, 162 are transitioned to the second state(e.g., the guide wire 74 can remain spatially stationary as the outersheath assembly 80 is proximally retracted), with the first tube 160slightly deflecting relative to the outer shaft 104 and the second tube162 slightly deflecting relative to the valve retainer 90 in accordancewith the changing geometries.

The connector assemblies of the present disclosure are configured toaccommodate relative movements of the outer sheath assembly 80 relativeto the inner shaft assembly 82 for a plethora of different deliverydevice designs. As a point of reference, the distance of travel of theouter sheath assembly 80 relative to the inner shaft assembly 82 indeploying the stented prosthetic heart valve (not shown) can be on theorder of 50-100 mm, for example about 70 mm.

The delivery system 70 can be used in performing a therapeutic procedureon a defective heart valve of a patient. For example, FIG. 6Aillustrates an aortic valve 200 target site. An introducer 202 can beused to initially place the guide wire 74 into the patient, with adistal end 204 of the guide wire 74 being advanced in a retrogrademanner through a cut-down to the femoral artery, into the patient'sdescending aorta, over the aortic arch, through the ascending aorta, andacross the defective aortic valve 200. A relatively short length 206 ofthe guide wire 74 remains outside of the introducer 202, and is lessthan a length of the delivery device 72 (FIG. 3B).

The delivery device 72 (in the delivery condition with a stentedprosthetic heart valve (hidden)) is then loaded on to the availablelength 206 of the guide wire 74 as described above and as generallyreflected by FIG. 6B. The delivery device 72 is advanced over the guidewire 74, bringing the capsule 88 to a desired location relative to thenative aortic valve 200 (e.g., slightly proximal the native valve 200).The handle assembly 84 is then operated to retract the outer sheathassembly 80 relative to the inner shaft assembly 82 (referencedgenerally) to effectuate deployment of the prosthetic heart valve 30 asin FIG. 6C. With this movement, the outer sheath assembly 80 slides overor relative to the guide wire 74 such that the guide wire 74 remainsspatially stationary. In some instances, prior to full deployment of thestented prosthetic heart valve 30, an optional partial deployment andevaluation procedure can be performed in which the prosthetic heartvalve 30 is partially deployed from the delivery device 72 and aposition of the so-deployed region relative to the implant site isevaluated. If desired, the delivery device 72 can optionally beconfigured to effectuate recapture of the partially deployed prosthesis,for example by distally advancing the capsule 88 relative to the innershaft assembly 82 and back over the prosthetic heart valve 30. Underthese circumstances, the connector assembly 86 (FIG. 4) can beconfigured to permit this relative movement.

The devices, systems, and methods of the present disclosure can beuseful in performing a therapeutic procedure on any defective valve ofthe patient's heart (i.e., aortic, mitral, pulmonic or tricuspid), andcan also be utilized to deploy a replacement valve into a previouslyimplanted prosthetic heart valve. With the aortic valve repairprocedures of FIGS. 6A-6C, and with other procedures, the anatomicalpathway may subject the delivery system 70 to significant turns or bends(e.g., as the delivery device system traverses the aortic arch). Tobetter ensure that the guide wire 74 generally follows a curved shape ofthe delivery device 72 along the anatomical bend but does not slide withthe delivery sheath assembly 80 due to a frictional interface along thebend (thus avoiding “cheese-wiring” of the anatomical tissue), thedelivery devices of the present disclosure can optionally include one ormore support bodies along an exterior of the outer sheath assembly 80.For example, FIG. 7 illustrates another delivery system 250 inaccordance with principles of the present disclosure in simplified form,and includes a delivery device 252 and the guide wire 74. The deliverydevice 252 can be highly akin to the delivery device 72 (FIGS. 3A and3B) described above, and can include any or all of the featurespreviously described. In addition, the delivery device 252 includes oneor more support bodies 260 along an exterior of the outer shaft 104proximal the guide wire exit port 92. The support bodies 260 aregenerally configured to slidably receive the guide wire 74, andgenerally retain the guide wire 74 in close but spaced proximity to theouter shaft 104. The support bodies 260 can assume a variety of forms,and in some embodiments are akin to an eyelet. The number and locationof the support bodies 260 relative to the capsule 88 corresponds withthe expected, small radius bend (due to the anatomical pathway) in thedelivery device 252 upon achieving the final delivery position. Thesupport bodies 260 ensure that the guide wire 74 remains connected to,but slightly spaced from, the delivery device 252 along the tight bendor turn, and thus minimizes surface contacts between the guide wire 74and the delivery device 252 and subsequently frictional forces betweenthe guide wire 74 and the delivery device 252.

Portions of another delivery system 300 in accordance with principles ofthe present disclosure are shown in FIGS. 8A and 8B. The delivery system300 includes a delivery device 302 and the guide wire 74. The deliverydevice 302 can assume a wide variety of forms, and generally includes anouter sheath assembly 310, an inner shaft assembly 312, and a reliefassembly 314. The outer sheath assembly 310 can assume any of theconfigurations described above, and in general includes or defines acapsule 320 and a guide wire exit port 322 (referenced generally). Theinner shaft assembly 312 can also assume any of the forms describedabove, and defines a guide wire lumen 330. The relief assembly 314includes a base 340 and a coil spring 342. The base 340 is attached tothe inner shaft assembly 312. The coil spring 342 is co-axially receivedover the inner shaft assembly 312, located between the capsule 320 andthe base 340. More particularly, a distal end 344 of the coil spring 342is located proximate the capsule 320, and a proximal end 346 of the coilspring 342 is located proximate the base 340.

In the delivery condition of FIG. 8A, the guide wire 74 is slidablyreceived within the guide wire lumen 330. The guide wire 74 exits theguide wire lumen 330 proximate the distal end 344 of the coil spring342, and extends along a spacing between the coil spring 342 and theinner shaft assembly 312. The guide wire 74 is further slidably receivedwithin the base 340, and extends proximally from the guide wire exitport 322. Upon transitioning of the delivery device 302 to thedeployment condition of FIG. 8B, the movement of the capsule 320 causesthe coil spring 342 to compress in a direction of the base 340. Theguide wire 74 freely resides in the spacing between the coil spring 342and the inner shaft assembly 312 such that the guide wire 74 experiencesminimal, if any, friction-type forces as the prosthetic valve 30(schematically illustrated) is deployed.

Portions of another delivery system 400 in accordance with principles ofthe present disclosure are shown in FIG. 9. The delivery system 400includes a delivery device 402 and the guide wire 74. The deliverydevice 402 can assume a wide variety of forms as described above, andgenerally includes an outer sheath assembly 410, an inner shaft assembly412 (referenced generally), and a relief assembly 414. The outer sheathassembly 410 can have any of the forms described above, and forms acapsule 420 and an outer shaft 422 defining a guide wire exit port 424.The inner shaft assembly 412 can also have any of the forms describedabove, and defines a guide wire lumen 430. The relief assembly 414 canbe formed in tandem with the inner shaft assembly 412, and includes aplurality of clips 440. The clips 440 can have a C-shape construction,configured to facilitate captured passage of the guide wire 74.

More particularly, one of the clips 440 is shown in greater detail inFIG. 10A. The clip 440 can be a C-clip, defined by overlapping, firstand second ends 442, 444. As reflected by FIGS. 10B and 10C, the clipends 442, 444 can be deflected away from one another to permit insertionof the guide wire 74 into an interior space of the clip 440. Once theguide wire 74 is inserted, the clip 440 self-reverts back to the naturalstate of FIG. 10C, thereby capturing the guide wire 74.

Returning to FIG. 9, the relief assembly 414 facilitates loading of theguide wire 74 into the guide wire lumen 430, and directs the guide wire74 from the guide wire lumen 430 to the guide wire exit port 424. Theguide wire 74 is thus slidably received by the delivery device 402, witha location of the guide wire exit port 424 being akin to a rapidexchange design.

Although the present disclosure has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges can be made in form and detail without departing from the spiritand scope of the present disclosure.

1-20. (canceled)
 21. A delivery device for implanting a stentedprosthetic heart valve, the device comprising: a handle; an inner shaftassembly extending from the handle and including a shaft and a valveretainer, the inner shaft assembly defining a guide wire lumen; acapsule slidably received over the inner shaft assembly, wherein thecapsule is configured to compressibly retain a stented prosthetic heartvalve; a guide wire exit port proximal of the capsule and distal of thehandle, wherein the delivery device is configured such that the capsuleis moveable relative to the guide wire exit port.
 22. The deliverydevice of claim 21, wherein the delivery device is configured to providea delivery condition in which a stented prosthetic heart valve iscompressed over a support segment of the inner shaft assembly andretained within the capsule.
 23. The delivery device of claim 22,wherein the delivery device is further configured to provide adeployment condition in which the capsule is proximally retracted fromthe support segment.
 24. The delivery device of claim 21, furthercomprising a coil spring proximal the capsule and distal the guide wireexit port and co-axially received over the inner shaft assembly, whereinmovement of the capsule in a proximal direction compresses the coilspring.